Implant device, tool, and methods relating to treatment of paranasal sinuses

ABSTRACT

An implant device is configured to be implanted in a fistula to fluidly connect the lacrimal apparatus and a paranasal sinus. A surgical tool has an implant the implant device mounted on a carrier. Various methods involve a fistula between the lacrimal apparatus and a paranasal sinus. A kit includes an entry device for use to form a fistula and an implant tool for use to implant an implant device following formation of a fistula.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/039,661, entitled “KIT FOR TREATMENT OF SINUSITIS,” filed Jul. 19,2018 and further identified as U.S. Pat. No. 11,110,256, which is acontinuation of U.S. patent application Ser. No. 15/077,020, entitled“IMPLANT DEVICE, TOOL, AND METHODS RELATING TO TREATMENT OF PARANASALSINUSES”, filed Mar. 22, 2016 and further identified as U.S. Pat. No.10,035,004, which is a divisional of U.S. patent application Ser. No.13/877,893 having a 371(c) date of Apr. 4, 2013 (now issued as U.S. Pat.No. 9,308,358), which U.S. patent application Ser. No. 13/877,893 is aU.S. national stage under the Patent Cooperation Treaty of internationalPatent Application No. PCT/US2011/055456 filed Oct. 7, 2011, whichinternational Patent Application No. PCT/US2011/055456 claims thebenefit of U.S. Provisional Patent Application No. 61/404,716 filed Oct.8, 2010 and U.S. Provisional Patent Application No. 61/528,058 filedAug. 26, 2011, and which international Patent Application No.PCT/US2011/055456 is a continuation-in-part of U.S. patent applicationSer. No. 13/225,213, filed Sep. 2, 2011 (now issued as U.S. Pat. No.9,022,967). The contents of each and every portion of each of theforegoing patent applications and patents are incorporated by referenceherein as if set forth herein in full for all purposes.

FIELD OF THE INVENTION

The invention relates to treatment of conditions of the paranasalsinuses, including with respect to implant devices, surgical tools andmethods.

BACKGROUND OF THE INVENTION

In the United States alone, 35 million people a year are treated forsinus infections, or sinusitis, and 7 million of those will suffer fromchronic sinusitis and will have minimal response to prescription drugtherapies. Current surgical interventions may be expected to, at best,offer only moderate symptomatic improvement but no cure.

Current drug therapies include oral administration as pills and nasaltopical administration, neither of which is conducive to deliveringadequate concentration of medication to the involved paranasal sinus. Inaddition to medication, frequent sinus irrigation can be helpful influshing out debris, irritants and obstructing viscous fluids, butpatients are generally not able to adequately perform this procedure athome.

For patients with particularly severe symptoms, surgical drainage may bethe only additional option. An early surgical procedure was theCaldwell-Luc procedure, which involves creating a permanent fistula fromthe base of the paranasal sinus into the oral cavity above the frontupper incisors. More recently, other surgical access points to theparanasal sinuses have been attempted. A variety of endoscopictechniques have been developed that access the paranasal sinuses throughthe nose, including functional endoscopic sinus surgery (FESS) andballoon sinuplasty. All attempt to increase drainage, but utilizedifferent routes or tools. None of these surgical approaches hasachieved wide-spread success, and millions of chronic sinusitis patientscontinue to suffer long-term disability and discomfort.

SUMMARY OF INVENTION

A variety of medical treatments and medical procedures directed to theparanasal sinuses may be performed through a fistula that may be formedbetween the lacrimal apparatus and a paranasal sinus. Such a fistulaprovides direct access from the lacrimal apparatus to the paranasalsinus in a minimally invasive manner. Such direct access permits drugsto be conveniently administered for local treatment in the paranasalsinus, rather than having to rely on systemic drug treatments. Suchdirect access permits irrigation fluids to be conveniently introducedinto the paranasal sinus. Such access permits fluids to be convenientlyremoved from the paranasal sinus. Such access permits a variety ofmedical procedures to be conveniently performed in the paranasal sinus.

A first aspect of the invention involves an implant device forimplantation in a human to fluidly connect the lacrimal apparatus to aparanasal sinus through such a fistula. The implant device has aproximal end and a distal end located at opposite longitudinal ends ofthe device. A conduit extends from adjacent the proximal end to adjacentthe distal end. An internal passage extends between the proximal end andthe distal end, and including through the conduit. The internal passagehas a first end open at the proximal end of the implant device and asecond end open at the distal end of the implant device. The implantdevice includes a length longitudinally along the device between theproximal end and the distal end that is in a range of from 2 millimetersto 50 millimeters. A width of the internal passage transverse to thelength is in a range of from 0.25 millimeter to 5 millimeters. Theimplant device is configured to be implanted to fluidly connect thelacrimal apparatus to the paranasal sinus through the fistula so thatwhen the implant device is implanted: the proximal end is disposed withthe first end of the internal passage opening in the lacrimal apparatus;the distal end is disposed in the paranasal sinus with the second end ofthe internal passage opening in the paranasal sinus; and the conduit isdisposed through the fistula.

A number of feature refinements and additional features are applicableto the first aspect of the invention. These feature refinements andadditional features may be used individually or in any combination. Assuch, each of the following features may be, but are not required to be,used within any other feature or combination of features of the firstaspect or any other aspects of the invention.

The conduit may be configured so that an exterior of the conduitcomprises an anchoring surface feature which assists to anchor theimplant device when the device is implanted. The anchoring surfacefeature includes protrusion areas and recess areas. The implant devicemay be configured so that when implanted the conduit is disposed throughthe fistula with at least a portion of the recess areas disposed withinthe fistula and with at least a portion of the protrusion areas disposedin the fistula and engaging tissue exposed within the fistula to anchorthe implant device. The structural and mechanical characteristics ofprotrusion occurrences in the protrusion areas may affect anchoringperformance of the protrusion areas. The height of the protrusion areasrelative to the recess areas may affect anchoring effectiveness when theimplant device is implanted. A larger height may provide greater anchoreffectiveness, but also may involve a larger overall width of theimplant device that must be inserted into the fistula. The protrusionareas may have a height relative to the recess areas of at least 0.1millimeter, at least 0.2 millimeter, at least 0.25 millimeter or atleast 0.3 millimeter. The protrusions areas may have a height relativeto the recess areas of no greater than 2 millimeters, no greater than1.5 millimeter, no greater than 1 millimeter, no greater than 0.75millimeter, no greater than 0.5 millimeter or no greater than 0.4millimeter. The height may be of particular protrusion occurrencesrelative to adjacent areas of recesses. Protrusion occurrences are alsoreferred to herein as anchor protrusions. Such anchor protrusions may beconfigured to flexibly deform when the conduit is inserted through thefistula for implantation, for example to flexibly deform in a directionopposite the direction of insertion when the anchor protrusions contacttissue disposed in the fistula during insertion. After insertion, theanchor protrusions may over time return to their original shape andextend deeper into adjacent tissue to better anchor the implant device.The mechanical properties of the anchor protrusions may be influenced bymaterials of construction. Preferred materials of construction for theprotrusion areas, and also for the portions of the implant device, arepolymeric materials. The polymeric materials may preferably be medicalgrade materials.

Some preferred polymeric materials are silicones and polyurethanes. Forenhanced performance, the material of construction should have arigidity that interacts positively with tissue in the vicinity of thefistula, for example to promote load sharing and good anchoring. Onepreferred material of construction is a polymeric material (e.g.silicone or polyurethane) having a durometer (Shore A) in a range havinga lower limit of 50, 60, 70 or 80 and an upper limit of 100, 80, 70 or60, provided that the upper limit must be larger than the lower limit.One preferred range is for a durometer (Shore A) of 60-100, with a rangeof 80-100 being even more preferred. For some implementations thepolymeric material has a durometer (Shore A) of about 60, of about 80 orof about 100. Mechanical properties of the protrusion occurrences of theprotrusion areas will also be affected by the geometry of the protrusionoccurrences. The protrusion occurrences may have a width that tapers, ornarrows, in a direction from a base toward a top of the protrusionoccurrences, with the base being a portion of a protrusion occurrencedisposed toward the internal passage of the conduit and a top of theprotrusion occurrence being the extremity of the protrusion occurrenceaway from the internal passage of the conduit. The width may betransverse to the length of the conduit. The protrusion occurrences mayhave a width at the base that is no larger than 2 millimeters, no largerthan 1.5 millimeters, no larger than 1.25 millimeters or no larger than1 millimeter. One or more of the protrusion occurrences may have a widthat the base that is at least 0.2 millimeter, at least 0.3 millimeter, atleast 0.5 millimeter, at least 0.75 millimeter or at least 1 millimeter.The protrusion occurrences may have a width adjacent the top that is nolarger than 0.75 times width at the base, no larger than 0.5 times thewidth at the base, or no larger than 0.25 times the width at the base.The protrusion occurrences may have a width midway between the base andthe top that is no larger than 0.8 times the width of the base, nolarger than 0.7 times the width of the base, no larger than 0.6 timesthe width of the base or no larger than 0.5 times the width at the base.

The protrusion areas may be provided by a single protrusion occurrencefeature located to correspond with the interior of the fistula when theimplant device is implanted. In more preferred implementations, theprotrusion areas include multiple protrusion occurrences spaced on theexterior of the conduit. The protrusion occurrences may have acenter-to-center spacing, in one or more directions, of at least 0.5millimeter, at least 0.75 millimeter, at least 1 millimeter or at least1.75 millimeters. The protrusion occurrences may have a center-to-centerspacing of no greater than 2.5 millimeters, no greater than 2millimeters or no greater than 1.75 millimeters. The protrusionoccurrences may have a center-to-center spacing longitudinally along theconduit. The protrusion occurrences may have a center-to-center spacingthat is at least 0.5 times the base width of the protrusion occurrences,or at least 1 times the base width of the protrusion occurrences or atleast 2 times the base width of the protrusion occurrences. Theprotrusion occurrences may have a center-to-center spacing that is nomore than 5 times a base width of the protrusion occurrences, no morethan 3 times a base width of the protrusion occurrences or no more than2 times a base width of the protrusion occurrences.

The protrusion areas may be located on a longitudinal portion of theconduit that includes at least a portion of the conduit that will bedisposed within a fistula when the implant device is implanted. Theprotrusion areas may be on a longitudinal portion of the conduit thatextends for at least 2 millimeters along the length of the implantdevice, that extends for at least 3 millimeters along the length of theimplant device, that extends for at least 4 millimeters along the lengthof the implant device, that extends for at least 5 millimeters along thelength of the implant device or that extends for at least 8 millimetersalong the length of the implant device. A longitudinal portion of theconduit including the protrusion areas may be no longer than 20millimeters, no longer than 15 millimeters or no longer than 10millimeters. A longitudinal portion of the conduit including theprotrusion areas may be disposed at least 2 millimeters from theproximal end of the device, at least 3 millimeters from the proximal endof the device, or at least 4 millimeters from the proximal end of thedevice. When the implant device has a head, a longitudinal portion ofthe conduit including the protrusions may be disposed at least 1millimeter, at least 2 millimeters or at least 3 millimeters from thehead. Providing significant distance between the head and commencementof the protrusion areas permits the head to better “float” on thesurface of tissue, which may enhance patient comfort and deviceperformance. The protrusion areas may be disposed along a longitudinalportion of the conduit with the protrusion areas covering no more than35% of the area along that longitudinal portion of the conduit, no morethan 25% of the area along that longitudinal portion of the conduit ornot more than 20% of the area along that longitudinal portion of theconduit. Providing significant spacing between protrusion occurrencesmay permit better engagement of tissue by the anchoring surface feature.

The protrusion areas may comprise at least one circumferential ridge. Bycircumferential ridge is meant a ridge that extends around an entirecircumference of the conduit. The protrusion area may comprise at leasttwo, at least three or at least five circumferential ridges. Theprotrusion areas may comprise a spiral ridge. Such a spiral ridge mayextend along a longitudinal portion of the conduit. The protrusion areasmay comprise a knob or may comprise multiple knobs. The anchoringsurface feature may comprise a textured surface, with the protrusionareas comprising protruding portions of the textured surface and therecess areas comprising recess portions of the textured surface.

The implant device may comprise a distal anchoring or retention featurethat will be disposed in the paranasal sinus when implanted. Such adistal feature may include, for example, barbs or other featuresconfigured to be disposed distal of the fistula and in the paranasalsinus when the implant device is implanted and to provide a barrier toremoval of the implant device from the fistula by withdrawal from theproximal end of the fistula. Such a feature may automatically deploy oninsertion through the fistula. Such a distal feature may be used with orwithout use also of anchor protrusions to engage tissue within thefistula, and such a distal feature may extend peripherally beyond aperipheral extend of such anchor protrusions when the implant devicealso includes such anchor protrusions for engaging tissue within thefistula.

The length of the implant device may be selected within the generalrange stated above to provide sufficient conduit length for extendingthrough the entire length of the fistula plus any extension distancedesired in the lacrimal apparatus proximal to the fistula and in theparanasal sinus distal to the fistula. The length of the conduit may bein a range having a lower limit of 2 millimeters, 3 millimeters, 4millimeters, 5 millimeters or 8 millimeters and an upper limit of 50millimeters, 40 millimeters, 30 millimeters, 20 millimeters, 15millimeters or 10 millimeters. One preferred range for someimplementations when the fistula is between the orbit and the ethmoidsinus or the maxillary sinus is for the length of the implant device tobe in a range of from 5 millimeters to 20 millimeters, with a range offrom 8 millimeters to 15 millimeters being more preferred. By length ofthe implant device it is meant the dimension longitudinally along thedevice from the proximal end to the distal end, and may be along alongitudinal axis through the internal passage. The length may be astraight line, for example when the internal passage is straight, or thelength may be curvilinear or some other shape, for example when theinternal passage is not linear. When a reference is made herein totransverse to the length, the reference is to a right angle to thelongitudinal direction of the length at that point (e.g., right angle toa line of the length or to a line tangent to a curve of the length).

The implant device may advantageously be designed with a conduit ofappropriate width dimensions to fit snuggly within a desired size offistula. The implant device may have a first exterior width dimensiondefined by a maximum extent of the protrusion areas transverse to thelength of the device, with the exterior width being within a rangehaving a lower limit of 0.75 millimeter, 1 millimeter, 1.25 millimeters,1.5 millimeters, 1.75 millimeters or 2 millimeters and an upper limit of8 millimeters, 7 millimeters, 6 millimeters, 5 millimeters, 4millimeters, 3 millimeters, 2 millimeters or 1.75 millimeters, providedof course that the upper limit must be larger than the lower limit. Theconduit may have a second width dimension defined by the minimum extentof the recess areas transverse to the length of the device, and whichsecond exterior width dimension will be smaller than the first exteriorwidth dimension defined by the protrusion areas. The second exteriorwidth dimension defined by the recess areas may be smaller than theexterior width dimension defined by the protrusion areas by an amountwithin a range having a lower limit of 0.2 millimeter, 0.25 millimeter,0.35 millimeter or 0.5 millimeter and having an upper limit of 1.5millimeters, 1 millimeter or 0.75 millimeter. The height of theprotrusion areas may be one-half the difference between the firstexterior width and the second exterior width. Either one of or each oneof the first exterior width and the second exterior width may be thediameter of a circle.

The implant device may comprise a plurality of apertures through a wallof the conduit to provide fluid communication from outside of theconduit to the internal passage in the conduit. The apertures may belocated on a portion of the conduit designed to be distal to the fistulaand located in a paranasal sinus when the implant device is implanted.Some or all of the apertures may be located along the length of thedevice at least 5 millimeters from the proximal end, at least 8millimeters end from the proximal end or at least 10 millimeters fromthe proximal end. The width of such an aperture may be equal to or maybe smaller than a width of the portion of the internal passage intowhich the aperture opens.

The implant device may include a head adjacent to the conduit at theproximal end of the implant device. The implant device may be configuredso that when the implant device is implanted, the head is disposed inthe lacrimal apparatus, and preferably with the head located in theorbit. The head may beneficially keep the implant device from migratingthrough the fistula toward the paranasal sinus following implantation ofthe implant device. The head may comprise a flanged tissue engagementsurface on a side of the head disposed toward the conduit and configuredto engage tissue outside of and adjacent to the fistula when the implantdevice is implanted. The flanged tissue engagement surface may be a flatsurface. The flanged tissue engagement surface may have non-flat surfacefeatures configured to improve seating of the surface against tissue,such as for example to inhibit rotation of the implant device within thefistula after implantation. The head may have a face surface oppositethe flanged tissue engagement surface and also disposed away from theconduit and disposed away from tissue engaged by the flanged tissueengagement surface when the implant device is implanted. The facesurface may be substantially flat. The face surface may be disposed atthe proximal end of the implant device and the internal passage may openat the face surface. The separation distance between the face surfaceand the flanged tissue engagement surface may be in a range having alower limit of 0.25 millimeter, 0.5 millimeter or 0.75 millimeter andhaving an upper limit of 2 millimeters, 1.5 millimeters or 1 millimeter.Such separation distance need not be constant across the flanged tissueengagement surface and face surface. A maximum separation distancebetween the face surface and the flanged tissue engagement surface maybe referred to as the depth of the head, and such depth may be in arange described above for the separation distance between the facesurface and the flanged tissue engagement surface. The flanged tissueengagement surface need not be continuous and may be divided intomultiple distinct surface portions. For example, the flanged tissueengagement surface may include a first flanged portion disposed to oneside of the internal passage and a second flanged surface portiondisposed to a second side of the internal passage that is opposite thefirst side. Each of the face surface and the flanged tissue engagementsurface may have a length dimension that represents a maximum separationdistance between points on an outer edge of the respective surface, andmay each have a width dimension that is a maximum separation distancebetween points on the outer edge transverse to the length dimension. Thelength dimensions of the face surface and the flanged tissue engagementsurface may be the same or may be different. The width dimensions of theface surface and the flanged tissue engagement surface may be the sameor may be different. The face surface and the flanged tissue engagementsurface may have corresponding outer edges. The length dimension of anyor all of the face surface, the flanged tissue engagement surface andthe head may be larger than a first exterior width of the conduitdefined by an extent of the protrusion areas transverse to the length ofthe implant device, when the implant device includes an anchoringsurface feature such as summarized above. The length dimension of any orall of the face surface, the tissue engagement surface and the head maybe in a range having a lower limit of 1 millimeter, 2 millimeters, 3millimeters, 4 millimeters or 5 millimeters and an upper limit of, 10millimeters, 8 millimeters or 7 millimeters. The width dimension of anyor all of the face surface, tissue engagement surface and the head maybe in a range having a lower limit of 0.5 millimeter, 1 millimeter, 1.5millimeters or 2 millimeters and an upper limit of 5 millimeters, 4millimeters or 3 millimeters. The length dimension of any or all of theface surface, the flanged tissue engagement surface and the head may beat least 1 millimeter, at least 2 millimeters, at least 3 millimeters orat least 4 millimeters larger than such first exterior width of theconduit defined by an extent of the protrusion areas, when the implantdevice includes an anchoring surface feature such as summarized above. Aratio of the length of any of or all the face surface, the flangedtissue engagement surface and the head to such a first exterior width ofthe conduit may be at least 2. Such a ratio may be smaller than 4. Thewidth of any or all of the face surface, the flanged tissue engagementsurface and the head may be not larger than, or may be smaller than(e.g., by at least 0.1 mm or by at least 0.2 mm), such a first exteriorwidth of the conduit defined by an extent of the protrusion areas, whenthe implant device includes an anchoring surface feature such assummarized above. A ratio of the length dimension to the width dimensionfor any or all of the face surface, the flanged tissue engagementsurface and the head may be in a range having a lower limit of 1, 1.5, 2or 2.5 and an upper limit of 5, 4, 3 or 2.5, provided of course that theupper limit must be larger than the lower limit. Having a larger lengthdimension to width dimension on the head is particularly preferred whenthe head will be located in the orbit between the lacrimal caruncle andthe plica semilunaris, because the length dimension may advantageouslyalign in a vertical direction next to the eyeball and will help providesufficient flanged surface area to effectively anchor the implant deviceon the proximal end and impede conjunctival tissue from covering theopening into the internal passage of the implant device, compensatingfor the narrower width. This is particularly advantageous when usingpolymeric materials of construction as described above.

The internal passage may have a substantially uniform shape along theentire length of the implant device, or may have a varying shape. Theinternal passage may be substantially straight from the proximal end ofthe device to the distal end of the device. The internal passage mayhave a cross-section available for flow (transverse to the length of thedevice) that is substantially uniform from the proximal end to thedistal end of the implant device. The internal passage may have asubstantially circular cross-section. The internal passage may have asubstantially elliptical cross-section. The width of the conduit(maximum dimension across the cross-section of the internal passageavailable for flow) may be in a range having a lower limit of 0.25millimeter, 0.5 millimeter or 0.75 millimeter and 1 millimeter and anupper limit of 5 millimeters, or 4 millimeters or 3 millimeters, 2millimeters or 1.5 millimeters.

The implant device may be configured for implantation with the conduitpassing through a fistula between a location in a lacrimal apparatuswithin the orbit and a paranasal sinus selected from the groupconsisting of a frontal sinus, an ethmoid sinus, a maxillary sinus and asphenoid sinus, with a frontal sinus, a maxillary sinus or an ethmoidsinus being preferred, with an ethmoid sinus or a maxillary sinus beingmore preferred, and with an ethmoid sinus being particularly preferred.The implant device may be configured for implantation with the conduitpassing through a fistula between a location in the lacrimal apparatuswithin the nasolacrimal duct and a paranasal sinus selected from thegroup consisting of an ethmoid sinus and a maxillary sinus. The locationwithin the nasolacrimal duct may be within the lacrimal sac.

The implant device may be disposed within a human body as implanted withthe conduit passing through a fistula between the lacrimal apparatus andthe paranasal sinus and with the proximal end located within thelacrimal apparatus and the distal end located within the paranasalsinus, with a preferred implementation including the distal end locatedin a paranasal sinus selected from the group consisting of an ethmoidsinus, the maxillary sinus and a frontal sinus and the proximal endlocated in the orbit, and more preferably with the proximal end disposedbetween the plica semilunaris and the lacrimal caruncle.

The implant device is primarily configured for and described herein withprimary reference to the implant device being implantable in a fistulathat may be formed between the lacrimal apparatus and a paranasal sinusto provide a passage from the lacrimal apparatus to the paranasal sinus.The implant device is also implantable in a fistula that may be formedbetween the lacrimal apparatus (e.g., from the corner of medial portionof the orbit between the lacrimal caruncle and the plica semilunaris)and the nasal cavity, for example for enhanced drainage of lacrimalfluid, and such applications directed to the nasal cavity are within thescope of the different aspects of the invention.

A second aspect of the invention is provided by a surgical toolcomprising an implant device and a carrier. The carrier includes amember with a distal tip, and the member is adapted to be disposedthrough a fistula between the lacrimal apparatus and a paranasal cavitywith the distal tip located in the paranasal cavity. The carrier alsoincludes a hand-manipulable handle connected to the member. The implantdevice is mounted on the carrier between the handle and the distal tip,with the member disposed through the internal passage and with aproximal end of the implant device disposed toward the handle and adistal end of the implant device disposed toward the distal tip. Thecarrier is disengageable from the implant device for implant placementof the implant device disposed through the fistula.

A number of feature refinements and additional features are applicableto the second aspect of the invention. These feature refinements andadditional features may be used individually or in any combination. Assuch, each of the following features may be, but are not required to be,used with any other feature or combination of features of the secondaspect or any other aspects of the invention.

The implant device may be an implant device according to the firstaspect of the invention. The implant device may be of a design otherthan according to the first aspect of the invention.

The distal tip of the member may be a piercing tip configured forpiercing tissue to form a fistula (e.g., a sharp tip). The distal tip ofthe member may be a blunt tip designed to enter and advance through afistula that has already been formed. The carrier may have an internalpassage extending through the handle and the member and through whichpassage a guide wire may be passed to help guide the carrier to alocation where an implant device is to be implanted in a fistula.

The member may be a solid member with the distal tip being a distal endof the solid member. The implant device may be mounted on the solidmember with the solid member disposed through an internal passage of theimplant device. The solid member may comprise a trocar or a stylet.

The member may be a hollow member. The implant device may be mounted onthe hollow member with the hollow member disposed through an internalpassage of the implant device. The distal tip may comprise a distal endof the hollow member. The hollow member may be a hollow needle or acannula. The carrier may comprise a syringe hub in fluid communicationwith the hollow interior of the member. The syringe hub may be connectedwith a proximal end of the hollow member. The syringe hub may be orcomprise a part of the handle. The syringe hub may be adapted forconnecting with a syringe to permit performance of at least oneoperation selected from the group consisting of injecting fluid from thesyringe through the hollow member and aspiration of fluid through thehollow member into a syringe. Such a hub may be configured to make aluer connection with a syringe. The carrier may comprise another member,which may be a solid member disposed through such a hollow member. Thedistal tip of the carrier may comprise a distal end of the solid member.The solid member may be slidably removable from a proximal end of thehollow member. The solid member may be disengageable from the hollowmember. The solid member may be a stylet or a trocar. The solid membermay have a distal end that is in the form of a blunt tip, or thattogether with a distal end of the hollow member may form a blunt tip.

The distal end of the member, and the distal tip, may be located atleast 0.3 centimeter, at least 0.5 centimeter, at least 0.75 centimeteror at least 1 centimeter from a distal end of the implant device. Thedistal end of the member, and the distal tip, may be located not morethan 5 centimeters, not more than 3 centimeters or not more than 2centimeters from the distal end of the implant device. The distal end ofthe member, and the distal tip, may be located at least 0.75 centimeter,at least 1 centimeter or at least 2 centimeters from the proximal end ofthe implant device. The distal end of the member, and the distal tip,may be located not more than 7 centimeters, not more than 6 centimeters,not more than 5 centimeters, not more than 4 centimeters or not morethan 3 centimeters from the proximal end of the implant device.

As with the first aspect, so also the surgical tool of the second aspectmay be used to implant an implant device (e.g., of the first aspect)through a fistula between the lacrimal apparatus and the nasal cavity.

Other aspects of the invention are provided by various methods involvinga fistula formed between the lacrimal apparatus of a human and aparanasal sinus. The fistula involved with any of these methods may besurgically formed by any appropriate technique between a location in thelacrimal apparatus of a human and a paranasal sinus. The fistula may beformed by a piercing or cutting instrument, such as for example aneedle, cutting cannula, trocar or stylet. Other example techniques forforming the fistula include drills, lasers, radio frequency (RF) andultrasound. The fistula may be formed using a surgical tool of thesecond aspect of the invention. The fistula may be formed by anyappropriate route connecting a location in the lacrimal apparatus withthe paranasal sinus of interest. The route of the fistula may be fromthe orbit to a frontal sinus, an ethmoid sinus or a maxillary sinus. Theroute may be subconjuctival from the orbit and through a wall of thefrontal, ethmoid or maxilla bone, as the case may be. The fistula may bebetween the nasolacrimal duct and either a maxillary sinus or an ethmoidsinus. The location and the nasolacrimal duct where the fistula isformed may be in a top part of the nasolacrimal duct known as thelacrimal sac or may be in a location in the nasolacrimal duct below thelacrimal sac. Although not generally a preferred route, the fistula maybe to the sphenoid sinus, such as subconjunctivally from the orbit andthrough a wall of the sphenoid bone to the sphenoid sinus. The fistulamay be a durably patent fistula, for example when access to theparanasal sinus is desired over an extended period of time. The fistulamay be more temporary in nature and formed to perform a single procedureafter which it is desired that the fistula will quickly repair andclose.

The fistula involved with methods of the invention may be formed byaccessing a location in the lacrimal apparatus where the proximal end ofthe fistula is to be located, and the fistula is then formed throughtissue into the target paranasal sinus. The location in the nasolacrimalduct may be accessed through the nasolacrimal duct, such as when thelocation where the fistula is to be formed is located in thenasolacrimal duct. The location in the lacrimal apparatus (e.g.,lacrimal sac portion of nasolacrimal duct) may be accessed through acanaliculus. Access to the lacrimal duct or lacrimal sac may also be viaa percutaneous or sub-conjunctival route, from which location a fistulamay be formed from the lacrimal duct or lacrimal sac into the targetparanasal sinus. Access to the nasolacrimal duct may also be through thebuccal gingival reflection, passing through the maxillary sinus, and thefistula may then be formed from the nasolacrimal duct to the ethmoidsinus. When the location where the fistula will be formed is in theorbit, access may be directly to the orbit. In some situations thefistula may be formed surgically by first accessing the target paranasalsinus and then surgically forming the fistula from the paranasal sinusinto a target location in the lacrimal system. For example, themaxillary sinus may be accessed percutaneously, sub-conjuntivally orthrough the buccal gingival reflection, and then from the maxillarysinus a fistula may be formed from the maxillary sinus to thenasolacrimal duct or lacrimal sac. As another example, the frontal sinusmay be accessed percutaneously and then from the frontal sinus a fistulamay be formed from the frontal sinus into the orbit or lacrimal sac. Forsituations when the fistula is between a location in the lacrimalapparatus that is in the nasolacrimal duct or the lacrimal sac and theparanasal sinus, all or a portion of the lacrimal apparatus from thepuncta to the location in the nasolacrimal sac or the nasolacrimal ductmay be intubated. Such intubation may, for example include a conduitthat extends from a punctum through a canaliculus and to the location inthe lacrimal sac or nasolacrimal duct. Such a conduit may be an integralpart of an implant device that passes through the fistula into theparanasal sinus.

When a method involves a treatment formulation (also referred to as atreatment composition) the treatment formulation may be a drugformulation (also referred to as a drug composition), for example fortreatment of sinusitis or some other condition. Such a drug formulationmay include one or more than one drug. Some example drugs that may beincluded in such a drug formulation include anti-inflammatories,antimicrobials, analgesics, mucolytics, antivirals, decongestants,steroids, antihistamines, antibiotics and anti-fungals. Such a treatmentformulation may be an irrigation fluid, for irrigating the paranasalsinus.

Some specific methods of the invention involving a fistula between alacrimal apparatus of a human and paranasal sinus are summarized below.

A third aspect of the invention is provided by a method for providingaccess to a paranasal sinus of the human to permit performance ofmedical treatments or procedures in the paranasal sinus over an extendedtime. The method comprises creating a surgically formed, durably patentfistula between the lacrimal apparatus of the human and the paranasalsinus.

A number feature refinements and additional features are applicable tothe third aspect of the invention. These feature refinements andadditional features may be used individually or in any combination. Assuch, each of the following features may be, but are not required to be,used with any other feature or combination of the third aspect or anyother aspects of the invention.

One or more techniques may be used to help maintain durable patency ofthe fistula for an extended period of time. One technique for impartingdurable patency is to, during the creating, surgically form the fistulawith a relatively large diameter, and preferably with a clean cut toform the fistula. Such large diameter openings of clean cut tissue arehighly resistant to natural repair mechanisms and such a fistula mayremain open for a significant amount of time, which may essentially bepermanent. The fistula may be formed with a diameter of at least 2millimeters, or at least 3 millimeters. The fistula may be not greaterthan 6 millimeters, not greater than 5 millimeters, not greater than 4millimeters or not greater than 3.5 millimeters. Another technique forimparting durable patency to the fistula comprises disposing through thefistula an implant device. The implant device occupies space within thefistula and prevents tissue from repairing and closing the fistula. Theimplant device may comprise an internal passage extending across theentire length of the fistula. A conduit of the implant device made to bedisposed through the fistula to maintain patency. The implant device maybe according to the first aspect of the invention. The implant devicemay be other than according to the first aspect of the invention. Theimplant device may be implanted using a surgical tool of a second aspectof the invention. The fistula may be formed using a surgical toolaccording to the second aspect of the invention. Forming the fistula mayinclude formation of the fistula using one surgical tool and implantingthe implant device with a different surgical tool. The fistula may bedilated between initial formation of the fistula and implantation of theimplant device. One or more procedures may be aided by the use of aguide wire extending through the fistula. For example, implantation ofthe implant device may involve the use of such a guide wire. As anotherexample, dilation of the fistula may involve the use of such a guidewire. Another technique that may be used to impart durable patency tothe fistula comprises mechanical treatment of tissue adjacent to fistulato inhibit tissue repair and closing of the fistula. One mechanicaltreatment technique may be over-sewing tissue adjacent to the fistula.Another mechanical treatment technique may be stapling tissue adjacentto the fistula. Another technique for imparting durable patency to thefistula is treating tissue adjacent the fistula with a substance (e.g.,a drug) effective to inhibit natural repair of the fistula. Thesubstance may include an antigranulation agent or an anti-scarringagent. The substance may comprise a steroid. The substance may compriseMitomycin C.

The method may include performing a procedure involving introduction ofa treatment formulation through the fistula into the paranasal sinus.Such a treatment formulation may include a drug formulation. Such atreatment formulation may include an irrigation fluid for irrigating theparanasal sinus. The method may comprise a procedure involving removalof fluid from a paranasal sinus. Such removal may be effected by gravitydrainage when the fistula is to a location in the lacrimal apparatus ata lower elevation than the paranasal sinus (e.g., fistula from frontalsinus to orbit). Introducing a treatment formulation into the paranasalsinus or removing fluid from the paranasal sinus, as the case may be,may be performed through a hollow member disposed through the fistula.Treatment formulation may be injected into the paranasal sinus from sucha hollow member and fluid may be removed by aspiration from theparanasal sinus through such a hollow member. Such a hollow member maybe disposed through the fistula contemporaneously with formation of thefistula. The hollow member may be a hollow member of a surgical toolaccording to the second aspect of the invention. The invention maycomprise performing a procedure at a later time not contemporaneous withforming the fistula. The method may comprise performing a treatmentcomprising administering a treatment formulation to the vicinity of theeye to flow from the lacrimal apparatus through the fistula into theparanasal sinus. The treatment formulation may be administered in theform of eye drops. The treatment composition may be an ophthalmiccomposition.

A fourth aspect of the invention is provided by a method for deliveringa treatment formulation to a paranasal sinus of a human. The methodcomprises administering the treatment formulation for delivery to theparanasal sinus through a fistula formed between the lacrimal apparatusof a human and a paranasal sinus.

A number of feature refinements and additional features are applicableto the fourth aspect of the invention. These feature refinements andadditional features may be used individually or in any combination. Assuch each of the following features may be, but are not required to be,used with any other features or combination of the fourth aspect or anyother aspects of the invention.

The administering may comprise injecting the treatment formulation intothe paranasal sinus from the hollow member disposed through the fistula.Such a hollow member may be a hollow needle or cannula. The fistula maybe a surgically formed, durably patent fistula. The fistula may be notdurably patent. The hollow member may be disposed through the fistulafor the purpose of delivering the treatment composition, after which thehollow member may be removed to permit the fistula to repair and close.

The administering may comprise administering the treatment formulationto the vicinity of an eye to flow from the lacrimal apparatus throughthe fistula and into the paranasal sinus. The treatment composition maybe administered in the form of eye drops. The eye drops may be anophthalmic composition.

A fifth aspect of the invention is provided by a method for performing amedical procedure in a paranasal sinus. The method comprises aspiratingfluid from or injecting fluid into the paranasal sinus through a conduitof a medical device while the conduit is disposed through the fistulabetween the lacrimal apparatus and the paranasal sinus.

A number feature refinements and additional features are applicable tothe fifth aspect of the invention. These feature refinements andadditional features may be used individually or in any combination. Assuch, each of the following features may be, but are not required to beused with any other feature or combination features of the fifth aspector any other aspects of the invention.

The conduit may be a conduit of an implant device. The implant devicemay be according to the first aspect of the invention. The implantdevice may be other than as according to the first aspect of theinvention. The conduit may comprise a hollow member disposed through thefistula with the tip of the hollow member disposed within the paranasalsinus. Such a hollow member may be, for example, a hollow needle or acannula. The fluid may comprise a treatment formulation.

A sixth aspect of the invention is provided by a method for treating aparanasal sinus of a human. The method comprises transmitting lacrimalfluid from the lacrimal apparatus through a surgically formed, durablypatent fistula between the lacrimal apparatus of the human and aparanasal sinus.

A number of feature refinements and additional features are applicableto the sixth aspect of the invention. These feature refinements andadditional features may be used individually or in any combination. Assuch each of the following features may be, but are not required to be,used with any other feature or combination of features of the sixthaspect or any other aspects of the invention.

Lacrimal fluid (tears) have significant therapeutic properties andproviding a supply of lacrimal fluid to a paranasal sinus may have abeneficial effect concerning sinus conditions, such as sinusitis. Thefistula may be maintained durably patent by any appropriate technique ortechniques, such as those discussed previously. The fistula may bemaintained as durably patent by an implant device with an internalpassage providing fluid communication between the lacrimal apparatus andthe paranasal sinus for conducting lacrimal fluid from the lacrimalapparatus to the paranasal sinus. The implant device may be according tothe first aspect of the invention. The fistula may be between locationsin the lacrimal apparatus and a paranasal sinus as previously described.One preferred fistula route is between the orbit and an ethmoid sinus.Another preferred fistula route is between the orbit and a maxillarysinus.

A seventh aspect of the invention is provided by a kit comprisingmultiple surgical tools. The kit includes a first surgical tool designedfor initially forming a fistula and a second surgical tool including animplant device and designed for implantation of an implant device in afistula after the fistula has already been formed to a desired size.

A number of feature refinements and additional features are applicableto the seventh aspect of the invention. These feature refinements andadditional features may be used individually or in any combination. Assuch each of the following features may be, but are not required to be,used with any other feature or combination of features of the seventhaspect or any other aspects of the invention.

The kit may include a third surgical tool designed to dilate a fistulaas initially formed using the first surgical tool. The kit may include aguide wire that may be used to guide tools to and through the fistula.The second surgical tool may be a surgical tool according to the secondaspect of the invention. The implant device of the second surgical toolmay be according to the first aspect of the invention. The implantdevice of the second surgical tool may be not according to the firstaspect of the invention.

Still other aspects of the invention are summarized below:

The present methods and inventions described below propose a novel wayto treat sinusitis that is much less invasive than even current advancedsurgical techniques. Natural tears are rich in lysozymes and otheragents that have potent antimicrobial activity and anti-inflammatoryproperties. The human eye produces an average of 300 micro liters oftears per day. These tears drain from the region of the medial canthusof the eye into a collection cistern, the naso-lacrimal sac (NLS) (alsoreferred to herein as the lacrimal sac) and are then pumped through thenasal-lacrimal duct (NLD) into the nasal cavity, bypassing the paranasalsinuses. Tear outflow is governed in part by contraction of theorbicularis oculi muscle plus passive and/or active participation by alacrimal pumping mechanism due to the helical arrangement of collagenand elastin fibers that make up the NLD. The NLS is separated from theethmoid sinuses (a common site for isolated sinusitis) by a thin boneywall. The mid portion of the NLD is also separated from the maxillarysinus by a thin boney wall.

For diagnostic and therapeutic purposes, the canaliculi of the lacrimalsystem can be cannulated with various probes. In addition, endoscopic orradiological (fluoroscopic or computed tomography (CT)) visualizationcan afford excellent navigational guidance to cannulate the NLS and NLD.The creation of a permanent or temporary communication between the NLSand the anterior ethmoid sinuses would allow direct constant flow ofantibiotic tears into the sinuses. Similarly, the creation of apermanent or temporary communication more inferiorly between the NLD andthe ipsilateral maxillary sinus would result in tear flow diversion intothis sinus cavity. In addition to providing a new method for drainingacute infections, this rerouting of lacrimal flow provides an effectivedelivery pathway for a host of ocular-safe active medications directlyinto the sinuses bypassing a major limitation to the medical treatmentof sinusitis. Medications that are highly likely to prevent and/or treatacute/chronic sinusitis include antibiotics (such as ofloxacin eyedrops), antihistamines, steroids, and even bacteriostatic saline eyedrops (natural tears).

Once an osteotomy between the NLS/NLD and the desired sinus cavity (thegeneral term for this would be dacrocystosinotomy) is procured (eitherfrom the lacrimal cannaliculi or the nasal orifice), a temporary orpermanent stent or portal could be inserted to ensure long-term patency.Such an otomy may be termed a dacrocystoethmoidotomy (NLS to ethmoidsinus) or a dacrocystomaxillotomy (NLD to maxillary sinus), analogous tothe currently performed dacrocystorihnotomy (wherein the NLD is openedinto the nasal cavity at a location superior to the normal drainageorifice). An alternate route of access into the NLD would be through theinferior meatus under the inferior turbinate. The following methods andinstruments capitalize on functional anatomy and physiology to optimizeflow diversion into desired areas and maintain patency of the osteotomyor osteotomies without compromising the normal pumping mechanism of theNLS/NLD. See FIGS. 1-3 for additional anatomic details

Some specific additional aspects of the invention, which may be combinedin any combination with other aspects of the invention, or any featuresthereof, contemplate:

1. A method to divert the tear duct pathway(s) from the superior andinferior canaliculus to the NLS & NLD and inferior meatus towards thetargeted paranasal sinuses and creating a conduit for the purpose oftreating a variety of sinus conditions that capitalizes on the naturalpumping mechanism of the NLS/NLD system.

2. A method to suction and/or drain and/or irrigate the target sinusonce this conduit has been established.

3. Tools or instruments to aid drainage of the target sinus, with orwithout guidance systems.

4. Methods and tool to maintain patency of the conduit otomy so thedesired drugs or other materials can be delivered to the target sinus totreat a variety of conditions, including stents, drains, certain drugs,or energy sources, such as light, acoustic, RF, heat, or cryo devices.

5. A method whereby the natural antimicrobial and anti-inflammatoryproperties of tears can be diverted into the target sinus to reducerecurrence, relapse, or chronicity of infectious or inflammatoryconditions.

6. If more than one sinus is targeted either on a single side orbilaterally, a method and tools to optimize flow dynamics preferentiallyinto or away from a desired sinus.

7. A method to perform this procedure as an office procedure withoutgeneral anesthesia using fluoroscopic guidance, cross sectional imagingguidance, endoscopic guidance, unguided with tactile and directionalfeedback, or a combination of the above.

8. A method to perform this procedure in an operative environment as anopen or image guided procedure as necessary.

9. A method to perform these procedures with 3D and or sterotacticguidance.

10. Methods and tools to access the NLS and/or NLD via a percutaneous orsub-conjunctival route.

11. Methods and tools to access the maxillary sinus through the buccalgingival reflection and thereby create a portal into the NLD.

12. Specialized instruments to access the NLS through the superior orinferior canaliculus and thereby create a conduit or portal throughwhich other instruments can be delivered.

13. Special coatings of tools to improve navigation of both rigid andflexible devises throughout desire anatomic areas.

14. The channels from the superior or inferior canaliculus into the NLSare mirror image to one another; these specialized instruments aredesigned to be reversible and ergonomically efficient for accessingeither portal of entry.

15. A method and tools to perform a dacrocystogram to aid fluoroscopicguidance.

16. Specialized instruments to access the NLD through the inferiormeatus and thereby create a conduit or portal through which otherinstruments can be delivered.

17. Method and instruments to pass a rigid, flexible, semi-flexible, orsteerable guide wire or other navigational device through the NLS andNLD, past the valve of Hasner to provide access for instruments via theinferior meatus.

18. Method and instruments to pass a rigid, flexible, semi-flexible, orsteerable guide wire or other navigational device through the NLS andNLD, from the inferior or superior canaliculus.

19. A method and instruments for creating an otomy between the NLS/NLDand the anterior ethmoid bulla.

a) Tools to create said otomy, include mechanical sources such as drillsand punches as well as energy sources (e.g. RF, LASER, and acoustic);

b) Specialized geometries of said instruments for optimize placement ofsaid otomy;

c) Specialized protective devises to maximize safety of otomy creation;and

d) The use of balloons, hooks, or other friction devices to anchor thedevice in the desired anatomy and thereby create a stable platform tocreate the otomy.

20. A method and tools for navigating throughout the ethmoid sinusesthrough said otomy with fluoroscopic or endoscopic guidance, or otherforms of imaging guidance including 3D or sterotactic virtual guidanceand navigation.

21. A method and tools for navigation throughout the ethmoid sinuses tocreate and insure patent communication between the ethmoid, sphenoid andfrontal sinuses so that each of these sinuses can also be treated by themethods described herein.

22. A method and instruments for creating an otomy between the NLS/NLDand the maxillary sinus.

a) Tools to create said otomy, include mechanical sources such as drillsand punches as well as energy sources (e.g. RF, LASER, and acoustic);

b) Specialized geometries of said instruments to optimize placement ofsaid otomy; and

c) Specialized protective devises to maximize safety of otomy creation.

23. Methods and instruments that capitalize on the natural functionalanatomy of the NLS and NLD to optimize flow diversion to desired areas.

24. Methods, tools and instruments, including special materials and orcoatings or capacity for drug elution to maintain patency of saidotomies.

25. Techniques to provide drug elution capability of any temporary orpermanent implant devices to aid healing patency, or optimize therapy.

26. Methods and tools to expand the otomy to a desired final diametervia mechanical methods such as a drill, punch, ronger, probe, orexpandable balloon.

27. Methods and tools to expand the otomy to a desired final diametervia energy sources such as light, heat, RF, or acoustic devices.

28. In certain cases, a method for delivery of a balloon expandable orselfexpandable stent or conduit through the otomy to help maintainpatency of said otomy.

29. Special design and techniques to manufacture said stent or conduitto insure long term patency.

30. Specialized geometries of said stent or conduit to optimize flowdiversion and help maintain patency of sad pathways.

31. Methods and instruments to optimally occlude the NLD in a temporaryor permanent manner to optimize flow diversion into the desired sinuscavities and away from the nasal cavity, including the use of energysources to occlude the sinus or the installation of temporary orpermanent occlusive structures.

32. A method of therapy to divert the tear duct pathway(s) from thenasallacrimal sac and duct to targeted paranasal sinuses, the methodhaving the steps:

a) inserting a surgical tool into the lacrimal sac or duct via theinferior or superior canaliculus;

b) guiding the tip of the surgical tool to a targeted spot adjacent tothe targeted paranasal sinus;

c) using the surgical tool to open a fistula in the septum between thelacrimal sac or duct and the targeted paranasal sinus; and

d) removing said surgical tool, to create conduits for tear orpharmaceutical flow into the targeted paranasal sinuses for the purposeof treating a variety of sinus conditions.

33. The method of number 32 wherein the targeted paranasal sinus is anethmoid sinus.

34. A method and tools to cannulate the frontal sinus via itscommunication with the ethmoid sinus at the frontal-ethmoidal recess orby direct perforation into this sinus for the treatment of frontalsinusitis.

35. A method and tools to cannulate the sphenoid sinus via itscommunication with the ethmoid sinus at the spheno-ethmoidal recess orby direct perforation into this sinus for the treatment of sphenoidsinusitis.

36. The method of number 32 wherein the targeted paranasal sinus is amaxillary sinus.

37. The method of number 32 wherein the diversion of the tear pathwaycapitalizes on the natural pumping mechanism of the nasal-lacrimal sacand duct system.

38. The method of number 32 wherein the procedure could be performed asan office procedure with or without general anesthesia, usingfluoroscopic guidance, cross sectional imaging guidance, endoscopicguidance, unguided with tactile and directional feedback, or acombination of the above.

39. The method of number 32 wherein surgical tools are used to cut orexcise tissue and bone between the nasal-lacrimal sac and duct and thetargeted paranasal sinuses.

40. A method of therapy to divert the tear duct pathway(s) from thenasallacrimal sac and duct to targeted paranasal sinuses, the methodhaving the steps:

a) inserting a surgical tool into the lacrimal duct via the valve ofHasner;

b) guiding the tip of the surgical tool to a targeted spot adjacent tothe targeted paranasal sinus;

c) using the surgical tool to open a fistula in the septum between thelacrimal duct and the targeted paranasal sinus;

d) removing said surgical tool, to create conduits for tear flow intothe targeted paranasal sinuses for the purpose of treating a variety ofsinus conditions.

41. The method of number 40 wherein the targeted paranasal sinus is anethmoid sinus & by extension, methods and tools to treat both thefrontal and sphenoid sinuses through the normal or created communicationpathways of these sinus cavities as in numbers 34 and 35.

42. The method of number 40 wherein the targeted paranasal sinus is amaxillary sinus.

43. The method of number 40 wherein the diversion of the tear pathwaycapitalizes on the natural pumping mechanism of the nasal-lacrimal sacand duct system.

44. The method of number 40 wherein the procedure could be performed asan office procedure with or without general anesthesia usingfluoroscopic guidance, cross sectional imaging guidance, endoscopicguidance, unguided with tactile and directional feedback, or acombination of the above.

45. The method of number 40 wherein surgical tools are used to cut orexcise tissue and bone between the nasal-lacrimal sac and duct and thetargeted paranasal sinuses.

46. A method of therapy to divert the tear duct pathway(s) from thenasallacrimal sac an d duct to targeted paranasal sinuses, the methodhaving the steps:

a) inserting a surgical tool directly into a maxillary sinus viapercutaneous methods and then creating a communication into the lacrimalduct;

b) guiding the tip of the surgical tool to a targeted spot adjacent tothe targeted paranasal sinus;

c) using the surgical tool to open a fistula in the septum between thelacrimal duct and the targeted paranasal sinus; and

d) removing said surgical tool, to create conduits for tear flow intothe targeted paranasal sinuses for the purpose of treating a variety ofsinus conditions.

47. The method of number 46 wherein the targeted paranasal sinus is anethmoid sinus & by extension, methods and tools to treat both thefrontal and sphenoid sinuses through the normal communication pathwaysof these sinus cavities.

48. The method of number 46 wherein the diversion of the tear pathwaycapitalizes on the natural pumping mechanism of the nasal-lacrimal sacand duct system.

49. The method of number 46 wherein the procedure could be performed asan office procedure with or without general anesthesia usingfluoroscopic guidance, cross sectional imaging guidance, endoscopicguidance, unguided with tactile and directional feedback, or acombination of the above.

50. The method of number 46 wherein surgical tools are used to cut orexcise tissue and bone between the nasal-lacrimal sac and duct and thetargeted paranasal sinuses.

51. A method of therapy to divert the tear duct pathway(s) from thenasallacrimal sac and duct to targeted paranasal sinuses, the methodhaving the steps:

a) inserting a surgical tool directly into the nasal lacrimal sac orduct via percutaneous or sub-conjunctival approaches and then creating acommunication from the lacrimal duct into the targeted sinus;

b) guiding the tip of the surgical tool to a targeted spot adjacent tothe targeted paranasal sinus;

c) using the surgical tool to open a fistula in the septum between thelacrimal duct and the targeted paranasal sinus; and

d) removing said surgical tool, to create conduits for tear flow intothe targeted paranasal sinuses for the purpose of treating a variety ofsinus conditions.

52. The method of number 51 wherein the targeted paranasal sinus is anethmoid sinus & by extension methods and tools to treat both the frontaland sphenoid sinuses through the normal communication pathways of thesesinus cavities.

53. The method of number 51 wherein the targeted paranasal sinus is amaxillary sinus.

54. The method of number 51 wherein the diversion of the tear pathwaycapitalizes on the natural pumping mechanism of the nasal-lacrimal sacand duct system.

55. The method of number 51 wherein the procedure could be performed asan office procedure with or without general anesthesia usingfluoroscopic guidance, cross sectional imaging guidance, endoscopicguidance, unguided with tactile and directional feedback, or acombination of the above.

56. The method of number 46 wherein surgical tools are used to cut orexcise tissue and bone between the nasal-lacrimal sac and duct and thetargeted paranasal sinuses.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration showing components of the lacrimal apparatus.

FIG. 2 is an illustration showing general locations of paranasalsinuses.

FIG. 3 is an illustration showing some example routes for fistulasbetween the lacrimal apparatus and the paranasal sinuses.

FIG. 4 is perspective view of one embodiment of an implant device.

FIG. 5 is a side view of the same embodiment of an implant device asshown in FIG. 4.

FIG. 6 is an end view of the same embodiment of an implant device asshow in FIG. 4.

FIG. 7 is a partial perspective view of the same embodiment of animplant device as shown in FIG. 4.

FIG. 8 is a partial side view of an embodiment of an implant device.

FIG. 9 is a partial side view of an embodiment of an implant device.

FIG. 10 is an illustration of cross-sections of various configurationsfor anchor protrusions for an implant device.

FIG. 11 is an illustration of various head configurations for an implantdevice.

FIG. 12 is a perspective view of an embodiment of an implant device.

FIG. 13 is an end view of the same embodiment of an implant device shownin FIG. 12.

FIG. 14 is an illustration showing an embodiment for placement of animplant device between the lacrimal caruncle and plica semilunaris.

FIG. 15 is a side view of an embodiment of an implant device.

FIG. 16 is a perspective view of an embodiment of a surgical tool.

FIG. 17 is a perspective view of an embodiment of a surgical toolshowing some components in exploded view.

FIG. 18 is a perspective view of the same embodiment of a surgical toolshown in FIG. 17, showing the surgical tool fully assembled.

FIG. 19 is a perspective view showing a first carrier piece of the sameembodiment of a tool shown in FIGS. 17 and 18, with the first carrierpiece connected with a syringe.

FIG. 20 is an illustration showing use of a surgical tool to form afistula between the orbit and an ethmoid sinus during a surgicalprocedure.

FIG. 21 is an illustration showing insertion of a guide wire followingformation of the fistula during a surgical procedure.

FIG. 22 is an illustration showing a guide wire in place as a guide to afistula during a surgical procedure.

FIG. 23 is an illustration showing use of a surgical tool forimplantation of an implant device during a surgical procedure.

FIG. 24 is an illustration showing placement of an implant devicefollowing implantation during a surgical procedure.

FIG. 25 is an illustration showing use of a surgical tool to dilate afistula following initial formation of the fistula during a surgicalprocedure.

DETAILED DESCRIPTION

The terms “lacrimal apparatus” and “lacrimal system” are usedinterchangeably herein to refer to the collection of physiologicalcomponents that accomplish the production and secretion of lacrimalfluid to lubricate the eyeball, containment of lacrimal fluid in areservoir of lacrimal fluid in the orbit and drainage of lacrimal fluidfrom the orbit to the nasal cavity. The lacrimal apparatus includes thelacrimal glands, the tear drainage system and the reservoir of lacrimalfluid located between the lacrimal glands and the tear drainage system.The reservoir of lacrimal fluid includes the eyelid margins and theconjunctival sac (and including the pool of tears in the lowerconjunctival cul-de-sac that is sometimes referred to as the lacrimallake). The tear drainage system includes the puncta, canaliculi andnasolacrimal duct (including the so-called lacrimal sac located at thetop of the nasolacrimal duct) through which excess tears drain toHasner's valve and into the nasal cavity. FIG. 1 shows generally thelacrimal apparatus. Lacrimal fluid is produced and secreted fromlacrimal glands 102 to lubricate the surface of the eyeball 104 disposedwithin the orbit. Lacrimal fluid forms a coating over the eyeball 104and is generally contained within the conjunctival sac (the spacebetween the lower eyelid 106, upper eyelid 108 and eyeball 104 that islined by the conjunctiva). Excess lacrimal fluid is conducted to thevicinity of the medial canthus (medial corner of the eye) and drainsthrough the lacrimal puncta 110 into the lacrimal canaliculi 112 andinto the lacrimal sac 114 of the nasolacrimal duct 116. The lacrimalfluid then drains from the nasolacrimal duct 116 through Hasner's valveand into the nasal cavity.

As used herein, a fistula between the lacrimal apparatus and a paranasalsinus refers to an artificially-created passage that fluidly connectsthe lacrimal apparatus with the paranasal sinus. The paranasal sinusesinclude the frontal sinuses, maxillary sinuses, ethmoid sinuses andsphenoid sinuses, which are cavities contained within frontal, maxilla,ethmoid and sphenoid bones, respectively. The paranasal sinuses draininto the nasal cavity. FIG. 2 is a schematic of a human head showinggenerally the locations of the frontal sinuses 122, the maxillarysinuses 124 and the ethmoid sinuses 126. The sphenoid sinuses (notshown) are located generally behind the ethmoid sinuses 126. FIG. 3shows generally some possible routes for a fistula between the lacrimalsystem and a paranasal sinus. Reference numerals indicate the samefeatures as shown in FIGS. 1 and 2, except as noted. FIG. 3 shows thegeneral proximity of the frontal sinus 122, maxillary sinus 124 andethmoid sinus 126 relative to features of the lacrimal apparatus. Someexample fistula routes are shown in FIG. 3 by dashed lines. A firstexample fistula route 130 is from the orbit to the frontal sinus. Asecond example fistula route 132 is from the orbit to the ethmoid sinus126. A third example fistula route 134 is from the orbit to themaxillary sinus 124. A fourth example fistula route 136 is from thelacrimal sac 114 at the top of the nasolacrimal duct 116 to the ethmoidsinus 126. A fifth example fistula route 138 is from the nasolacrimalduct 116 at a location below the lacrimal sac 114 to the ethmoid sinus126. A sixth example fistula route 140 is from the nasolacrimal duct 116at a location below the lacrimal sac 114 to the maxillary sinus 124. Theexample fistula routes shown in FIG. 3 are for purposes of generalillustration only and not show precise locations where a fistula mightbe formed to connect a part of the lacrimal apparatus with thecorresponding paranasal sinus. Although not shown in FIG. 3, examplefistula routes to the sphenoid sinus include from the orbit to thesphenoid sinus and from the nasolacrimal duct 116 to the sphenoid sinus.Forming a fistula to connect to the sphenoid sinuses is generally not aspreferred as forming a fistula to connect to the ethmoid sinus, forexample because it is generally more convenient and direct to connectwith the ethmoid sinus. Also, forming a fistula to either the ethmoidsinus 126 or the maxillary sinus 124 is generally preferred to forming afistula to the frontal sinus 122, with one reason being that a fistulabetween the lacrimal system and either the ethmoid sinus 126 or themaxillary sinus 124 may be formed in a way to obtain the benefit ofgravity to assist drainage of lacrimal fluid from the lacrimal systeminto the corresponding paranasal sinus through the fistula. The frontalsinus is located generally above the orbit and will not benefit in thesame way from gravity drainage of lacrimal fluid into the paranasalsinus. However, gravity drainage may beneficially assist drainage offluid from the frontal sinus.

With continued reference to FIG. 3, the first, second and third examplefistula routes 130, 132 and 134 are subconjuctival routes that penetratethe conjunctiva to directly connect the lacrimal fluid reservoir withinthe conjunctival sac to the corresponding paranasal sinus. A fistulaalong such a subconjunctival route may be surgically formed by asurgical tool piercing through the conjunctiva and the adjacent wall ofthe bone in which is disposed the corresponding paranasal sinus. Forexample, for the first example fistula route 130, the fistula would passsubconjunctivally from the orbit and through a wall of the frontal boneinto the frontal sinus 122. For example, a fistula following secondexample fistula route 132 would pass subconjuctivally from the orbit andthrough a wall of the ethmoid bone into the ethmoid sinus 126. Forexample, a fistula following the third example fistula route 134 wouldpass subconjuctivally from the orbit through a wall of the maxilla boneinto the maxillary sinus 124. Subconjuctival routes for a fistula suchas those of the first, second and third example fistula routes 130, 132and 134 are generally preferred as being formed at locations that arerelatively easy to access. In a preferred implementation of the first,second and third example fistula routes 130, 132 and 134, the proximalend of the fistula opening into the orbit is located between thelacrimal caruncle 142 and the plica semilunaris 144, shown in FIG. 3.

Continuing with reference to FIG. 3, a fistula at the fourth, fifth orsixth example fistula routes 136, 138 and 140 will have a proximal endopening into a location within the nasolacrimal duct 116. Formation of afistula in such a location requires insertion of a surgical tool intothe lacrimal drainage system, such as through the puncta 110 andcanaliculi 112 to access the nasolacrimal duct 116 or through the noseto access the nasolacrimal duct 116. For example, a fistula at thefourth example fistula route 136 may be formed by a piercing instrument(e.g., a trocar or trocar/cannula assembly) inserted into one of thepuncta 110, through one of the canaliculi 112 and across the lacrimalsac 114 to pierce a hole at the location of the fourth example fistularoute 136. As another example, a fistula may be formed at one of thefourth, fifth and sixth example fistula routes 136, 138 and 140 using aguide wire inserted into one of the puncta 110, through one of thecanaliculi 112, into the lacrimal sac 114 and downward through thenasolacrimal duct 116. The guide wire may be used to engage a surgicaltool and to guide the surgical tool from the nose through Hasner's valve(not shown) and to the appropriate location within the nasolacrimal duct116 to permit performance of a surgical operation at that location toform the desired fistula.

FIGS. 4-7 show one embodiment of an implant device. As shown in FIGS.4-7, an implant device 200 has a proximal end 202 and a distal end 204located on opposite longitudinal ends of the implant device 200. Theimplant device 200 includes a head 206 at the proximal end 202 and aconduit 208 extending from the head 206 to the distal end 204. Aninternal passage 210 extends from the proximal end 202 to the distal end204, passing through the head 206 and the conduit 208. The internalpassage 210 opens at the proximal end 202 and the distal end 204,thereby providing a passage through the entire longitudinal length ofthe implant device 200. The internal passage 210 of the embodiment shownin FIG. 4 has a cylindrical shape with a uniform circular cross-section(transverse to the length of the implant device 200), and the width ofthe internal passage is equal to the diameter of the circle of thecross-section and is uniform along the length of the implant device 200.The length of the implant device 200 is the minimum distancelongitudinally along the implant device 200 between the proximal end 202and the distal end 204, and will typically be equal to the distancealong an axis of the internal passage 210 from the proximal end 202 tothe distal end 204. The implant device 200 includes multiple anchorprotrusions 212 on an exterior of the conduit 208. In the embodimentshown in FIGS. 4-7, the anchor protrusions 212 are in the form of spacedcircumferential ridges that each extends around the entire circumferenceof the conduit 208. Adjacent the circumferential ridges of the anchorprotrusions 212 are areas of recess 214 on the exterior of the conduit208.

With continued reference to FIGS. 4-7, when the implant device isimplanted to fluidly connect the lacrimal apparatus to a paranasal sinusthrough a fistula, the head 206 is disposed in the lacrimal apparatusand the proximal end 202 is disposed in the paranasal sinus, and with atleast a portion of the conduit 208 disposed through the fistula with atleast one, and preferably more than one, of the anchor protrusions 212engaging tissue within the fistula to anchor the implant device 200.When implanted in this manner, the internal passage 210 opens into thelacrimal apparatus at the proximal end 202 and into the paranasal sinusat the distal end 204. The head 206 has a flanged tissue engagementsurface 216 on a side of the head 206 disposed toward the conduit 208,and which flanged tissue engagement surface 216 is advantageouslyconfigured to engage tissue adjacent the proximal end of fistula and toprevent the proximal end 202 of the implant device 200 from migratinginto the fistula following implantation. On the side of the head 206opposite the flanged tissue engagement surface 216 is a face surface 218of the head 206, which face surface 218 is disposed away from tissueengaged by the flanged tissue engagement surface 216 when the implantdevice is implanted. The head 206 has a first dimension 220 and a seconddimension 222 on both the flanged tissue engagement surface 216 and theface surface 218. The first dimension 220 is the length of therespective surface and the second dimension is the width of therespective surface. Such length and width dimensions may also bereferred to as major and minor dimensions. The first dimension 220 of asurface 216 or 218 corresponds to the maximum separation distancebetween points on the outer edge of the surface, and the seconddimension 222 of the surface 216 or 218 corresponds to the maximumseparation distance between points on the outer edge of the surface thatare on a line transverse to the first dimension. Conveniently, the facesurface 218 and the flanged tissue engagement surface 216 may be madewith corresponding outer edges, so that the opposing surfaces 216 and218 have substantially equal length and width dimensions, although suchis not required. The first dimension 220 and the second dimension 222may be referred to generally as the length and width, respectively, ofthe head 206 when the surfaces 216 and 218 have corresponding shapes, asis the case for the embodiment shown in FIGS. 4-7. When the surfaces 216and 218 do not have corresponding shapes, the length and widthdimensions of the head will be different from one or more of the lengthand width dimensions of the surfaces 216 and 218. The head 206 has adepth dimension 223 between surfaces 216 and 218. The depth dimension223 should preferably be kept to a small value so that the head 206 willhave a low profile adjacent the proximal end of the fistula when theimplant device 200 is implanted with the flanged tissue engagementsurface engaging tissue adjacent the proximal end of the fistula.

With continued reference to FIGS. 4-7, the conduit 208 has a firstexterior width 224 that is a maximum exterior width of the conduit 208as defined by the maximum extents of the anchor protrusions 212transverse to the length of the conduit 208. The conduit 208 has asecond exterior width 226 that is a minimum exterior width of theconduit 208 defined between the most recessed portions of the areas ofrecess 214. In the embodiment shown in FIGS. 4-7, the height of theanchor protrusions 212 is equal to one-half the difference between thefirst exterior width 224 and the second exterior width 226 of theconduit 208. In the configuration of the head 206 shown in FIG. 4-7, thefirst dimension 220 of the head is larger than both the first exteriorwidth 224 and the second exterior width 226 of the conduit 208, whilethe second dimension 222 of the head is approximately equal to thesecond exterior width 224 of the conduit 208.

With continued reference to FIGS. 4-7, the anchor protrusions 212 are inthe form of circumferential ridges having a width that is at a maximumat the bottom of the ridges located adjacent the areas of recess 214,and which width tapers to a minimum at the top of the ridges 212 locatedaway from the recess areas 214. Other configurations for anchorprotrusions are possible, and all anchor protrusions on an implantdevice need not be of the same size, geometry or height. Likewise, areasof recess may have varying configurations, and not all recesses on animplant device need to be the same size or configuration. The implantdevice 200 has a length 228 including the depth 223 of the head 206 andthe length of the conduit 208. The anchor protrusions 212 are on alongitudinal portion 230 of the conduit 208.

Referring now to FIG. 8, an alternative embodiment is shown of a conduit240 of an implant device having anchor protrusions 242 in the form ofknobs, or buttons, and areas of recess 244 adjacent the anchorprotrusions 242. The conduit 240 has a first exterior width 246 definedby the anchor protrusions 242 and a smaller, second exterior width 248defined by the areas of recess 244. An example of another configurationfor anchor protrusions is shown in FIG. 9. As shown in FIG. 9, a conduit250 of an implant device has anchor protrusions 252 and areas of recess254 on the exterior surface of the conduit 250. The anchor protrusions252 are in the form of a continuous spiral ridge extending along aportion of the longitudinal length of the conduit 250. The conduit 250has a first exterior width 256 defined by the anchor protrusions 254 anda smaller, second exterior width 258 defined by the areas of recess 254.As with the embodiments shown in FIGS. 4-7, the conduit embodiment shownin FIGS. 8 and 9 include a height of the anchor protrusions that isequal to one half the difference between the larger and smaller outerdiameters of the respective conduits. As will be appreciated from theembodiments of FIGS. 8 and 9, the first exterior width is determined asthe width of an envelope volume that contains the anchor protrusions.

FIG. 10 shows examples of some shapes for anchor protrusions thatinclude a tapering width in a direction from the base of the anchorprotrusion toward a top of the anchor protrusion. FIG. 10 showscross-sections of anchor protrusion configurations (designated A-D),each having a greater width at the base than at the top. The height (H)and base width (W) of the anchor protrusions are indicated in FIG. 10.The cross-sections shown in FIG. 10 may, for example, be across a ridge(e.g., circumferential ridge, spiral ridge), a knob protrusion or otheranchor protrusion form. All of the anchor protrusion configurations A-Din FIG. 10 are shown with a leading side of the anchor protrusion on theright side and a trailing side on left side of the anchor protrusion. Byleading side it is meant a side that enters the fistula first when aconduit containing the anchor protrusion is inserted into the fistulafor implantation. By trailing side it is meant the side opposite theleading side and that enters the fistula after the leading side. As willbe appreciated, forces applied to the anchor protrusions by tissuecontacting the anchor protrusions during insertion into a fistula willimpart stresses to the anchor protrusions and, to an extent as permittedby the material of construction of the anchor protrusion, such stresseswill tend to deform the anchor protrusion in a direction toward thetrailing side. Such deformation aids insertion, and is generallypreferred to some degree. The different shapes of the configurations A-Daffect the relative ease of insertion of a conduit into and removal ofthe conduit from a fistula. Configuration A is designed to be equallyeasy to insert and removable from a fistula while each of configurationsB-D are designed to be more easy to insert into a fistula and moredifficult to remove from the fistula. Configurations B and C are angledin a way to promote more easy insertion and more difficult removal froma fistula. Configuration D includes a hooked end to engage tissue on thetrailing side to make removal from a fistula more difficult thaninsertion.

FIG. 11 shows some different example configurations (designated E-H) fora head for an implant device. For each head configuration, the lengthdimension (L) and width dimension (W) of the head configurations areshown. The heads of configurations E-H are shown on end showing the facesurface (surface facing away from the fistula when implanted) and theopening of the internal passage at the proximal end of the implantdevice. For each of the head configurations E-H, the length and width ofthe face surface and the opposing flanged tissue engagement surface arethe same. As shown in FIG. 11, head configuration E has a circular outeredge, and thus has equal length and width dimensions. Head configurationF has an elongated length dimension relative to width dimension, similarto that shown in the implant device embodiment described with referenceto FIGS. 4-7. Head configuration G has an elongated length dimensionrelative to the width dimension, similar to configuration F, but forconfiguration G the internal passage opening at the proximal end of theimplant device has an elliptical cross-section, rather than a circularcross-section as is the case for configurations E and F. Headconfiguration H has a crescent-shaped head with a significantly largerlength dimension than width dimension. The internal passage forconfiguration H is also shown with an elliptical cross-section.Configurations F-H, with a larger length than width, are advantageouslyconfigured for use with fistulas opening into the orbit between theplica semilunaris and the lacrimal caruncle, with the length dimensionof the head extending generally in a direction from the bottom of theorbit toward the top of the orbit next to the eyeball, and forconfiguration H with the concave side of the crescent disposed towardthe eyeball and the convex side of the crescent disposed towards thelacrimal caruncle.

FIGS. 12 and 13 show another embodiment for an implant device. As shownin FIGS. 12 and 13, an implant device 300 has a proximal end 302 and adistal end 304, with a head 306 located at the distal end 304 and aconduit 308 extending from the head 306 to the distal end 304. Theconduit 308 includes an internal passage 310 with a cylindrical shapeand opening at the proximal end 302 and the distal end 304. The conduit310 has an exterior surface including anchor protrusions 312, in theform of circumferential ridges with tapering width, and areas of recess314 adjacent the anchor protrusions 312. The head 306 has an elongatedshape with a significantly larger length dimension 316 than widthdimension 318. As seen in FIG. 12, a flanged tissue engagement surface320 has a beveled configuration (beveled halves extending from centralline) to help seat against tissue in a manner to prevent rotation of theimplant device 300 when implanted. The face surface 322 is a flatsurface to provide a low profile to the head 306 when the implant device300 is implanted. The configuration of the head 306 is well suited forplacement between the plica semilunaris and lacrimal caruncle for usewith a subconjunctival fistula route from the orbit where the opening ofthe fistula into the orbit is located between the plica semilunaris andthe lacrimal caruncle. The length dimensions 316 and width dimension 318represents the length and width of each of the face surface 322 and theflanged tissue engagement surface 320.

FIG. 14 shows an example of an implant device with a conduit passingthrough a fistula formed subconjunctivally between the lacrimal caruncle350 and the plica semilunaris 352, and showing an example location forthe head 354 of the implant device. The head 354 is shown with anelongated configuration, such as for example the head configurationshown in FIGS. 4-7, one of the head configurations F-H shown in FIG. 11or the head configuration shown in FIGS. 12 and 13.

FIG. 15 shows another embodiment of an implant device. As shown in FIG.15, an implant device 400 has a proximal end 402 and a distal end 404.The implant device 400 includes a head 406 at the proximal end 402 and aconduit 408 extending from the head 406 to the distal end 404. Theconduit 408 has an exterior surface with anchor protrusions 412 andareas of recess 414 adjacent the anchor protrusions 412. An internalpassage 410 (shown by dashed lines) extends from the proximal end 402 tothe distal end 404. A distal longitudinal portion of the conduit 408includes apertures 415 through the wall of the conduit 408 and providingfluid communication from the internal passage 410 to outside of theconduit 408. The apertures 415 provide a route for drug formulations,irrigation solutions or other treatment compositions to exit from theinternal passage into different locations within a paranasal sinus whenthe implant device 400 is implanted. When the implant device 400 isimplanted, at least one or more of the anchor protrusions 412 will belocated within the fistula to engage tissue for anchoring and at leastsome, and preferably all, of the apertures 415 will be disposed beyondthe distal end of the fistula inside of a paranasal cavity. Theconfiguration shown in FIG. 15 is particularly advantageous forsituations when the conduit 408 extends through multiple cavities of aparanasal sinus or when the conduit 408 extends from one paranasal sinusinto another paranasal sinus. The embodiment shown in FIG. 15 does notinclude the anchor protrusions 412 on the longitudinal portion of theconduit 408 where the apertures 415 are disposed. As an alternativeconfiguration, the longitudinal portion of the conduit 408 including theapertures 415 could include anchor protrusions, of the sameconfiguration as those of the anchor protrusions 412 or of differentconfigurations.

FIG. 16 shows one embodiment of a surgical tool. As shown in FIG. 16, asurgical tool 500 includes an implant device 502 having a head 504 and aconduit 506, for example as previously described with respect to any ofthe FIGS. 4-15. The implant device 502 is mounted on a carrier 510. Thecarrier 510 comprises a handle 511 adjacent a proximal end of thesurgical tool 500. The carrier 510 includes a working member 512connected to the handle 511. The working member 512 extends from thehandle 511 through the internal passage of the implant device 502 and toa distal end of the surgical tool 500. At the distal end of the workingmember 512 is a distal tip 514. The handle 511 may be made of anyconvenient material of construction, for example plastic or metalliccompositions. The working member 512 may be made for example of amedical-grade metallic composition, such as a medical-grade stainlesssteel. In general when a member is referred to herein as a “workingmember”, the term indicates that the member is such that at least aportion of the member is designed for being disposed within or through afistula when a tool containing the member is used, for example duringformation of a fistula or during performance of some procedure in orthrough a fistula. Some examples of working members include varioushollow members (e.g., hypodermic needles, cannulas) and various solidmembers (e.g., trocars, stylets, dilating members, implant deliverymembers). Such a working member may be disposed in or through thefistula in a manner that the member contacts tissue in the fistula or ina manner not to contact tissue in a fistula (e.g., inside of a passageof an implant device passing through the fistula).

With continued to reference to FIG. 16, the implant device 502 ismounted on the carrier 510 with the working member 512 disposed throughthe internal passage of the implant device 502. The width of the workingmember 512 disposed through the internal passage of the implant device502 may advantageously be sized to be just smaller than the internalpassage of the implant device for a close fit between them, providedthat the fit is not so tight that the implant device 502 is difficult toslide down the working member 512 toward the distal tip 514.

Continuing to refer to FIG. 16, the surgical tool 500 may be used toform a fistula between the lacrimal system and a paranasal sinus and tofacilitate implantation of the implant device 502 in the fistula. Asurgeon may manipulate the surgical tool 500 by hand-grasping the handle511. The surgeon may advance the distal tip 514 to a location within thelacrimal apparatus where the fistula is to be formed to a targetparanasal sinus. The surgeon may then force the distal tip throughtissue separating the lacrimal apparatus and the target paranasal sinusto form the fistula. With a leading portion of the working member 512disposed through the fistula, a surgeon may slide the implant device 502along the working member 512 toward the distal tip 514 until the implantdevice 502 is positioned for implantation with the conduit 506 disposedthrough the fistula and a flanged tissue engagement surface of the head506 disposed against tissue adjacent the proximal end of the fistula inthe lacrimal apparatus, or the carrier may continue to be advanced topush the conduit 506 into the fistula. After the implant device 502 ispositioned for implantation, the surgeon may then manipulate the handle504 to retract the working member 512 to withdraw the working memberfrom the internal passage of the implant device 502 and to fullydisengage the carrier 510 from the implant device 502, leaving theimplant device 502 implanted with the conduit 506 extending through thefistula and into the paranasal sinus.

With continued reference to FIG. 16, the working member 512 may be asolid member (e.g., trocar, stylet) or may be a hollow member (e.g., ahollow needle, cutting cannula). If the working member 512 is a hollowmember with an opening at the distal tip 514, then tissue will tend tobe cored and collected in the hollow interior of the working member 512when the surgical tool 500 is used to form a fistula. If the workingmember 512 is a solid member, then tissue coring should not occur. Inmany instances, it may be preferred to have the working member 512 be asolid member that does not core tissue, because the implant device maytend to be held more securely within a fistula formed without tissuecoring. The surgical tool 500 shown in FIG. 16 is particularly welladapted for forming a fistula from the orbit subconjunctivally to aparanasal sinus, and particularly when the fistula is formed at alocation in the orbit between the plica semilunaris and the lacrimalcaruncle.

FIGS. 17 and 18 show another surgical tool. FIG. 17 shows an expandedview of some features of a surgical tool 520 and FIG. 18 shows the samesurgical tool 520 as the surgical tool 520 appears fully assembled. Asshown in FIG. 17, the surgical tool 520 includes an implant device 522with a head 524 and a conduit 526, for example as described previouslywith respect to any of FIGS. 3-16. The surgical tool 520 includes acarrier with two pieces, a first carrier piece 530 and a second carrierpiece 532. The first carrier piece 530 has a syringe hub 534 (e.g., formaking a luer connection) and a hollow working member 536 (e.g., hollowneedle, cannula) connected with the hub 534. The hollow working member536 has a distal tip 538. The second carrier piece 532 has a handle 540and a solid working member 542 (e.g., stylet, trocar) connected with thehandle 540. The solid working member 542 has a distal tip 544. Asassembled, the surgical tool 520 includes the solid working member 542inserted through the interior of the hub 534 and through the hollowinterior of the hollow working member 536. As assembled, the handle 540of the second carrier piece 532 is disposed distal of the hub 534 withan engagement member 544 inserted into the interior of the hub 534. Aswill be appreciated, features of the hub 534 and/or the engagementmember 544 and/or the handle 540 may contain keying and engagementfeatures to align and/or permit detachable engagement of the firstcarrier piece and the second carrier piece when assembled. FIG. 18 showsthe same surgical tool 520 as it appears fully assembled. As shown inFIG. 18, the first carrier piece 522 and the second carrier piece 532are engaged with the solid working member 542 disposed through thehollow interior of the hollow working member 536.

With continued reference to FIGS. 17 and 18, the surgical tool 520 maybe used to form a fistula between the lacrimal apparatus and a paranasalsinus. The distal tips 538 and 544 of the first and second carrierpieces 530 and 532 form a distal tip that will not significantly coretissue. A surgeon may grasp the handle 540 and advance the distal tip toa location in the lacrimal apparatus where the fistula is to be formed(e.g., in the orbit, in the nasolacrimal duct) and the distal tip maythen be forced through tissue into a paranasal sinus to form the fistulato the target paranasal sinus. With a leading portion of the hollowworking member 536 disposed through the fistula, the implant device 522may be slid down the hollow working member 536 and into position forimplantation with the conduit 526 disposed through the fistula and thehead 524 disposed adjacent the proximal end of the fistula, or thehollow working member 536 may be further advanced to push the conduit526 into the fistula. The hollow working member 536 may then beretracted and disengaged from the implant device 522 to leave theimplant device 522 in the implanted position.

Continuing with reference to FIGS. 17 and 18, the hollow working member536 facilitates performance of an ancillary medical procedure involvingaspirating fluid from or introducing fluid into the paranasal sinus. Forexample, before or after positioning the implant device 522 in theproper location for implantation, the second carrier piece 532 may bedisengaged from the first carrier piece 534 to remove the solid workingmember 542 from the hollow interior of the hollow working member 536.The hollow working member 536 is then available for aspiration of fluidfrom or injection of fluid into the paranasal sinus. The hub 534 may beengaged with a corresponding connection structure of a syringe and thesyringe may be operated to aspirate fluid from the paranasal sinus intothe syringe or to inject fluid from the syringe into the paranasalsinus. Fluids that may be injected into the paranasal sinus includeirrigation fluid or treatment compositions containing a drug, forexample to inject a drug bolus for treatment of sinusitis. As usedherein, “fluid” includes flowable compositions, including compositionsthat may have a solid material dispersed or suspended in a fluid medium.After the implant device has been properly positioned for implantationand after performing any desired ancillary medical procedure, the firstcarrier pierce may be retracted to disengage the hollow working member536 from the internal passage of the implant device 522 and to leave theimplant device 522 as an implant. FIG. 19 shows the first carrier piece536 of the surgical tool 500 connected with a syringe 550.

Referring now to FIGS. 20-25, some additional examples of surgicalprocedures involving forming a fistula and implanting an implant device,and some example surgical tools for use therewith, will now bedescribed.

In FIG. 20 a surgical tool in the form of an entry tool 600 is shown inthe process of making a fistula through tissue between the lacrimalcaruncle 142 and the plica semilunaris 144. Numbering of anatomicalparts is the same as in FIGS. 1 and 3. The fistula is formed throughtissue between the conjunctival sac in the orbit and the ethmoid sinus126. The route for the fistula would be consistent with general fistularoute 132 as shown in FIG. 3. The entry tool 600 includes a first piece602 and a second piece 604. The first piece 602 includes a hollowworking member 606 and a hub 608. The second piece 604 includes a solidworking member (not shown) disposed through a hollow interior of thehollow working member 606. A distal tip portion of the hollow workingmember 606 of the first piece 602 and a distal tip portion of the solidworking member of the second piece 604 form a distal tip 610 with ashape suitable for insertion through the tissue to form a fistula fromthe conjunctival sac to the ethmoid sinus 126. The second piece 604includes a hand-manipulable handle 612. The hub 608 may be configuredfor connecting with a syringe or other fluid manipulation device, suchas through a luer connection. The handle 612 may be retracted relativeto the hub 608 to remove the solid working member from the interior ofthe hollow working member 606 and to disengage the second piece 604 fromthe first piece 602. As shown in FIG. 20, the distal tip 610 has beenadvanced from a location in the conjunctival sac between the caruncle142 and the plica semilunaris 144 to form a fistula between theconjunctival sac and the ethmoid sinus 126. As shown, the fistula passesbehind the caruncle 142, canaliculi 112 and nasolacrimal duct 116 toaccess the ethmoid sinus 126. The first piece 602 of the entry tool 600includes a collar stop 614 to prevent the hollow working member 606 frombeing advanced through tissue beyond a certain distance. The first piece602 and the second piece 604 may, for example, be substantially the sameas the first carrier piece 530 and the second piece 532 of the toolassembly 520 of FIG. 17, but with the added collar stop 614 and notincluding an implant device mounted thereon.

After the entry tool 600 has been used to initially form a fistula tothe ethmoid sinus 126, then the second piece 604 may be disengaged fromthe first piece 602 and a guide wire inserted through the internalpassage through the hollow working member 606. FIG. 21 shows the firstpiece 602 after disengagement of the second piece 604 and afterinsertion of a guide wire 620 through the first piece 602 and exitingfrom a distal end of the first piece 602 in the ethmoid sinus 126. Afterinsertion of the guide wire 620, the first piece 602 may be retractedand removed from the fistula, leaving the guide wire 620 in place as aguide to and through the fistula. FIG. 22 shows the guide wire 620disposed through the fistula after removal of the first piece 602. Theguide wire 620 is now available for guiding additional tools to andthrough the fistula into the ethmoid sinus 126.

With reference now to FIG. 23, the guide wire 620 has been used to guidea surgical tool, in the form of an implant tool 624. The implant tool624 includes a hollow working member 626 and a hand-manipulable handle628. The implant tool 624 includes an internal passage passing throughthe handle 628 and the hollow working member 626. As shown in FIG. 23,the guide wire 620 has been threaded through the internal passage of theimplant tool 624 to guide the hollow working member 626 to and throughthe fistula and into the ethmoid sinus 126. The implant tool 624 alsoincludes an implant device 630 mounted on the hollow working member 626.FIG. 23 shows the implant tool 624 advanced to a point where the distalend of the implant device 630 is in the vicinity of the proximal end ofthe fistula opening into the conjunctival sac. From this position, theimplant device 630 may be advanced into the fistula with a head of theimplant device 630 disposed adjacent the conjunctiva in the conjunctivalsac and a distal end of the implant device 630 extending into theethmoid sinus 626. The implant tool 624 may, for example, be a tool ofthe design such as that shown for the surgical tool 500 in FIG. 16, witha hollow needle for the working needle 518. The implant device 630 ofthe implant tool 624 may, for example, have features as described withrespect to any of FIGS. 4-19. With the continued reference to FIG. 23,the hollow working member 626 of the tool 624 preferably includes ablunt tip. The handle 628 and the hollow working member 626 form acarrier for the implant device 630. The handle 628 may be retracted andthe hollow working member 626 disengaged from the implant device 630after the implant device has been appropriately positioned forimplantation through the fistula. As an alternative to the configurationof the implant tool 624 as shown in FIG. 23, the implant tool 624 couldbe configured to include a hub for connection (e.g., through a luerconnection) with a syringe of other fluid manipulation device. Forexample, the implant tool 624 could be configured with a hub in a mannersimilar to the configuration of the first piece 602 shown in FIG. 21 andwith the implant device appropriately mounted for implantation. Asanother variation on the configuration of the implant tool 624, theworking member 626 could be fitted with a collar stop (e.g., as shown inFIG. 21) or other mounting aid against which the implant device 630could be disposed to provide some additional distance between a proximalend of the implant device 630 and the handle 628. FIG. 24 shows theimplant device 630 as implanted and following disengagement of thehollow working member 626 of the implant tool 628. As implanted, a head632 at the proximal end of the implant device 630 is located adjacentthe conjunctiva in the conjunctival sac within the orbit between thecaruncle 142 and the plica semilunaris 144 and the distal end 634 of theimplant device 630 is located in the paranasal sinus 626. Some of anchorprotrusions 636 are disposed within the fistula to engage tissue andhelp anchor the implant device 630.

The procedure as described with reference to FIGS. 20-24 permits theworking member 606 of the entry tool 600 to have a larger diameterworking member 626 to form a fistula of appropriate size foraccommodating the implant device 630 which is then implanted in aseparate step using the implant tool 624 with the implant device 630carried on to the working member 626, which may advantageously have asmaller diameter then the working member 606 used to form the fistula.As an alternative, an intermediate step to dilate the fistula to adesired size for implantation may be performed between initially formingthe fistula with the entry tool 600 and implanting the implant device630 using the implant tool 624. FIG. 25 shows a surgical tool in theform of a dilator tool 640 having a hollow working member 642 and ahand-manipulable handle 644. The working member 642 is disposed throughthe fistula, guided by the guide wire 620 passing through an internalpassage through the dilator tool 640. As shown in FIG. 25, the workingmember 642 has been advanced to the point where a stop collar 646attached to the working member 642 has engaged conjunctival tissue inthe conjunctival sac adjacent a proximal end of the fistula. For thisalternative implementation, the hollow working member 642 of the dilatortool 640 would have a larger diameter than the hollow working member 606of the entry tool 600 shown in FIGS. 20 and 21. The hollow workingmember 642 of the dilator tool 640, therefore widens the fistula furtherto a desired size to accommodate easier insertion of the implant device630. Although the intermediate step of dilation as shown is notrequired, it permits the use of a smaller-diameter working member 606during initial formation of the fistula. The use of a smaller diameterfor the working member 606 to initially form the fistula permits bettervisibility and procedural control for a surgeon performing theprocedure. The working member 642 may preferably include a blunt tip.

In a method for providing access to a paranasal sinus to a human topermit performance of medical treatments or procedures in the paranasalsinus over an extended time, a surgically formed, durably patent fistulamay be created between the lacrimal apparatus of the human and theparanasal sinus. By surgically formed, it is mean that the fistula is anartificial passage through tissue that is intentionally formed by asurgical operation. For example, the fistula may be formed using atrocar, stylet, needle or cannula. The fistula may be formed by asurgical tool as described with reference to any of FIGS. 16-19. By“durably patent” it is meant that the fistula is resistant to closure bynatural tissue repair mechanisms and remains open (patent) for anextended period of time to provide access into the paranasal sinus overthe extended period of time. The extended period of time may be anyperiod of time sufficient for performing through the fistula any desiredmedical treatments or procedures. The extended period of time may, forexample, be at least 7 days, at least 14 days, at least 30 days, atleast 180 days, or longer. The extended period may be permanent.

A fistula may be maintained as durably patent for an extended period oftime by a variety of techniques. As one example for maintaining fistulapatency, an implant device may be disposed through the fistula toprevent the fistula from closing, and the implant device may include aninternal passage for providing access through the fistula into theparanasal sinus. When access to the paranasal sinus is no longerrequired, the implant device may be removed to permit tissue to repairand close the fistula. The implant device may, for example, have aconfiguration as described with respect to any of FIGS. 4-19 or may havea different configuration. As another example for maintaining fistulapatency, the fistula may be formed initially with a relatively largediameter, and preferably with a clean cut. A large, cleanly cut holewill naturally tend to remain patent and not repair for at least asignificant time. The relatively large diameter of the fistula may, forexample be at least 2 millimeters or larger, as described above. Whenthe fistula is formed with such a large diameter, the fistula willpreferably be formed at a location in the nasolacrimal duct. As anotherexample for maintaining fistula patency, after the fistula is formed thetissue adjacent the fistula may be mechanically treated to form amechanical impediment to tissue repair that would close the fistula. Themechanical treatment could involve, for example over-sewing tissueadjacent the fistula or stapling tissue adjacent the fistula tomechanically retain the tissue in a manner to inhibit tissue repair thatwould close the fistula. As another example for maintaining fistulapatency, tissue adjacent the fistula may be treated with a substance(e.g., a drug) effective to inhibit natural tissue repair and closure ofthe fistula, such as for example treatment with an antigranulation oranti-scarring agent (e.g., steroids, Mitomycin C).

A variety of medical treatments and procedures may be performed througha fistula formed between the lacrimal apparatus and a paranasal sinus,whether or not the fistula is durably patent. One or more medicaldevices may be inserted into the paranasal sinus through the fistula.For example a hollow working member (e.g., hollow needle, cannula) maybe inserted through the fistula into the paranasal sinus to permitaspiration of fluid from or injection of a treatment formulation (e.g.,drug formulation, irrigation fluid) into the paranasal sinus. As anotherexample, a treatment formulation (e.g., drug formulation, irrigationfluid) may be transmitted through the fistula into the paranasal sinusby natural flow from the lacrimal system. A treatment formulation may beadministered to the vicinity of the eye (e.g., as eye drops) tonaturally flow from the lacrimal apparatus through the fistula and intothe paranasal sinus. The fistula may, but need not necessarily be, adurably patent fistula. For example, a conduit of a medical device beinserted from the lacrimal apparatus through tissue and into theparanasal sinus, fluid may be aspirated through or injected from theconduit, and the conduit may then be removed to allow the fistula formedby insertion of the conduit to quickly repair. Such a conduit may, forexample, be a hypodermic needle or cannula (e.g., connected to asyringe, drip system or other fluid injection/aspiration system). Thefistula may be formed by insertion of a member including the needle orcannula and may naturally repair and close quickly following removal ofthe conduit. For example, the fistula may be formed by insertion of ahypodermic needle, a fluid may be injected or aspirated through thehypodermic needle and the hypodermic needle may then be removed topermit the fistula to repair. As another example, the fistula may beformed by a trocar/cannula assembly, the trocar may then be removed, amedical procedure performed through the cannula (e.g., fluid injectionor aspiration), and the cannula may then be removed to permit thefistula to repair. As another example, the fistula may be formed by acutting cannula, a medical procedure performed through the cannula(e.g., fluid injection or aspiration), and the cannula may then beremoved to permit the fistula to repair.

A surgically created, durably patent fistula may be advantageouslylocated for transmitting lacrimal fluid (tears) to a paranasal sinus.Lacrimal fluid from the lacrimal apparatus may be permitted to draininto the paranasal sinus. In one preferred implantation, thesurgically-created, durably patent fistula is from either the orbit orthe nasolacrimal duct to either the ethmoid sinus or the maxillarysinus, with a fistula route from the orbit being more preferred.

The foregoing discussion of the invention and different aspects thereofhas been presented for purposes of illustration and description. Theforegoing is not intended to limit the invention to only the form orforms specifically disclosed herein. Consequently, variations andmodifications commensurate with the above teachings, and the skill orknowledge of the relevant art, are within the scope of the presentinvention. The embodiments described hereinabove are further intended toexplain best modes known for practicing the invention and to enableothers skilled in the art to utilize the invention in such, or other,embodiments and with various modifications required by the particularapplications or uses of the present invention. It is intended that theappended claims be construed to include alternative embodiments to theextent permitted by the prior art. Although the description of theinvention has included description of one or more possibleimplementations and certain variations and modifications, othervariations and modifications are within the scope of the invention,e.g., as may be within the skill and knowledge of those in the art afterunderstanding the present disclosure. It is intended to obtain rightswhich include alternative embodiments to the extent permitted, includingalternate, interchangeable and/or equivalent structures, functions,ranges or steps to those claimed, whether or not such alternate,interchangeable and/or equivalent structures, functions, ranges or stepsare disclosed herein, and without intending to publicly dedicate anypatentable subject matter. Furthermore, any feature described or claimedwith respect to any disclosed implementation may be combined in anycombination with one or more of any other features of any otherimplementation or implementations, to the extent that the features arenot necessarily technically incompatible, and all such combinations arewithin the scope of the present invention.

The terms “comprising”, “containing”, “including” and “having”, andgrammatical variations of those terms, are intended to be inclusive andnonlimiting in that the use of such terms indicates the presence of somecondition or feature, but not to the exclusion of the presence also ofany other condition or feature. The use of the terms “comprising”,“containing”, “including” and “having”, and grammatical variations ofthose terms in referring to the presence of one or more components,subcomponents or materials, also include and is intended to disclose themore specific embodiments in which the term “comprising”, “containing”,“including” or “having” (or the variation of such term) as the case maybe, is replaced by any of the narrower terms “consisting essentially of”or “consisting of” or “consisting of only” (or the appropriategrammatical variation of such narrower terms). For example, a statementthat some thing “comprises” a stated element or elements is alsointended to include and disclose the more specific narrower embodimentsof the thing “consisting essentially of” the stated element or elements,and the thing “consisting of” the stated element or elements. Examplesof various features have been provided for purposes of illustration, andthe terms “example”, “for example” and the like indicate illustrativeexamples that are not limiting and are not to be construed orinterpreted as limiting a feature or features to any particular example.The term “at least” followed by a number (e.g., “at least one”) meansthat number or more than that number. The term at “at least a portion”means all or a portion that is less than all. The term “at least a part”means all or a part that is less than all.

What is claimed is:
 1. An implant device for implantation in a human tofluidly connect a lacrimal apparatus to a paranasal sinus through afistula formed between the lacrimal apparatus and the paranasal sinus,the implant device comprising: a proximal end at a first longitudinalend of the device; a distal end at a second longitudinal end of thedevice that is longitudinally opposite the first longitudinal end; aconduit extending from adjacent the proximal end to adjacent the distalend; an internal passage extending between the proximal end and thedistal end and through the conduit, the internal passage having a firstend open at the proximal end and a second end open at the distal end; alength of the device longitudinally along the device between theproximal end and the distal end in a range of from 2 millimeters to 50millimeters; a width of the internal passage transverse to the length ina range of from 0.25 millimeter to 5 millimeters; and an exterior of theconduit comprising an anchoring surface feature including protrusionareas and recess areas; the implant device configured to be implanted tofluidly connect the lacrimal apparatus to the paranasal sinus throughthe fistula so that when implanted: the proximal end is disposed withthe first end of the internal passage opening in the lacrimal apparatus;the distal end is disposed in the paranasal sinus with the second end ofthe internal passage opening in the paranasal sinus; and the conduit isdisposed through the fistula with at least a portion of the recess areasdisposed within the fistula and with at least a portion of theprotrusion areas disposed in the fistula and engaging tissue exposedwithin the fistula to anchor the implant device.
 2. An implant deviceaccording to claim 1, wherein the conduit is constructed of polymericmaterial having a durometer (Shore A) in a range of from 50 to 100.